APPLICATION
ANDA203974
TYPE
ANDA
ORIGINAL APPROVAL
2015-05-29
LATEST ACTION
2024-10-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METRONIDAZOLEPrescription
METRONIDAZOLE 250MG · TABLET · ORAL
METRONIDAZOLEPrescription
METRONIDAZOLE 500MG · TABLET · ORAL
Approval history
2024-10-25Labeling · Supplement 15 · standardAP
2024-07-08Labeling · Supplement 14 · standardAP
2024-01-09Labeling · Supplement 12 · standardAP
2022-03-31Labeling · Supplement 10 · standardAP
2021-08-19Labeling · Supplement 8 · standardAP
2019-07-29Labeling · Supplement 5 · standardAP
2017-09-05Labeling · Supplement 1 · standardAP
2015-05-29UNKNOWN · OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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